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Vaginal Microbiome and the Risk of Vulvovaginal Graft Versus Host Disease Following Hematopoietic Stem Cell Transplantation
Allogeneic stem cell transplantation (also termed "bone marrow transplantation") involves transferring stem cells from a healthy person (the donor) to the patient, after high-intensity chemotherapy or radiation, given to destroy any remaining cancer cells in the body. When a transplant is successful, the donor stem cells replace the original cells in the bone marrow. It may provide the only long-term cure of the patient's disease. Of transplant-related complications, graft-versus-host disease (GVHD) is one of the most important complications. GVHD arises from donor immune cells, that identify the recipient's (the patien's) cells as foreign and attack them. Approximately half of women undergoing transplantation will experience GVHD involving the genitalia (i.e., the vulva and vagina), termed vulvovaginal GVHD (VV-GVHD). VV-GVHD may cause irreversible anatomical changes, including complete vaginal obliteration, and not surprisingly, it has a severe impact on patients' quality of life and sexual function. This complication is unpredictable and non-preventable by the usual immunosuppressive treatment given to patients. Frequent gynecological examinations and prolonged follow-up of transplanted women are needed, to allow early diagnosis and prevention of harmful results of VV-GVHD. This follow-up adds inconvenience and anxiety to the patients. The suggested study aims to evaluate a possible association between vaginal microorganisms (the "microbiome") to the progress of VV-GVHD. Finding such association may allow prediction of VV-GVHD progress, a better understanding of the development of VV-GVHD and a potential to develop interventions for the treatment and prevention of VV-GVHD.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Start Date
February 15, 2022
Primary Completion Date
March 1, 2026
Completion Date
December 1, 2026
Last Updated
March 20, 2025
40
ESTIMATED participants
No intervention
OTHER
Lead Sponsor
Hadassah Medical Organization
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05694910